The data showed that Cimzia (certolizumab pegol) – the only PEGylated anti-TNF alpha (tumor necrosis factor alpha) – significantly improved endoscopic lesions and induced endoscopic response (as assessed by the Crohn’s Disease Endoscopic Index of Severity (CDEIS)) within 10 weeks of treatment in more than 60% of the moderate to severe Crohn’s disease patients studied.
Data from the 54-week, open-label Phase IIIb Mucosal improvement in patients with active Crohn’s disease treated with certolizumab pegol (Music) trial showed significant improvement by week 10 in CDEIS scores, the primary endpoint of the study. Scores dropped from 14.7 to 8.2 – a reduction of 6.5 points, or 44% improvement compared to baseline. The CDEIS, which ranges from 0 to 44 points, is used to assess the presence of mucosal lesions associated with inflammation along the lining of the gut (ileum, colon and rectum).
Improvements in secondary endpoints, including endoscopic remission and response rates, histological CD score, clinical remission rate and decrease in C-reactive protein level, also were achieved in this study. Specifically, the Crohn’s Disease Activity Index (CDAI), showed nearly half (46%) of the patients achieved clinical remission at week 10.
More than 40% of study participants achieved endoscopic remission (CDEIS score <6 points) by week 10. Meanwhile, more than 60% of the patients responded (defined as a reduction of five or more points in CDEIS scores) to Cimzia treatment. Significant improvements also were shown by histological analysis, the company said. The Music trial is an 89-patient Phase IIIb open-label 54-week trial designed to evaluate the efficacy of certolizumab pegol on resolving the intestinal mucosal lesions in patients with active Crohn's disease.